UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048557 |
|---|---|
| Receipt number | R000055319 |
| Scientific Title | Japan Nurses' Health Study: The Next Generation (JNHS-II) |
| Date of disclosure of the study information | 2022/08/02 |
| Last modified on | 2023/07/27 12:05:37 |
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Basic information
Public title
Japan Nurses' Health Study: The Next Generation (JNHS-II)
Acronym
JNHS-II
Scientific Title
Japan Nurses' Health Study: The Next Generation (JNHS-II)
Scientific Title:Acronym
JNHS-II
Region
| Japan |
Condition
Condition
Women's health
Classification by specialty
| Medicine in general | Surgery in general | Obstetrics and Gynecology |
| Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the relationship between the occurrence of various diseases peculiar to women and that of changes in lifestyle habits, health care habits, and reproductive events.
Basic objectives2
Others
Basic objectives -Others
The purpose of the 1st follow-up period (10 years) is obtaining knowledge about fertility preservation, and investigate the affect for long-term use of OC / LEP .
We will investigate the relationship about occurence of various diseases and the changes of lifestyle habits, helath care habits, and reproductive events, over the 2nd follow-up period and more.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
the 1st follow-up period:
infertility
the 2nd follow-up period:
menopausal symptoms, cancer, cardiovascular disease and osteoporosis
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 22 | years-old | <= |
Age-upper limit
| 50 | years-old | >= |
Gender
Female
Key inclusion criteria
Registered nurses, midwife, or public health nurse
Key exclusion criteria
Women aged more than 50 yeas old
Target sample size
20000
Research contact person
Name of lead principal investigator
| 1st name | Kazue |
| Middle name | |
| Last name | Nagai |
Organization
Gunma University
Division name
Center for Food Science and Wellness
Zip code
371-8514
Address
3-39-22 Showa-machi, Maebashi, Gunma, 371-8514 Japan
TEL
027-220-8974
kazue-nagai@gunma-u.ac.jp
Public contact
Name of contact person
| 1st name | Kazue |
| Middle name | |
| Last name | Nagai |
Organization
Gunma University
Division name
Center for Food Science and Wellness
Zip code
371-8514
Address
3-39-22 Showa-machi, Maebashi, Gunma, 371-8514 Japan
TEL
027-220-8974
Homepage URL
j-snow-jimukyoku@ml.gunma-u.ac.jp
Sponsor or person
Institute
Gunma University
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development (AMED)
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Gunma University
Address
3-39-22 Showa-machi, Maebashi, Gunma, 371-8511 Japan
Tel
027-220-8763
ciru_hitotaisho-irb@ml.gunma-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 08 | Month | 02 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2022 | Year | 06 | Month | 30 | Day |
Date of IRB
| 2022 | Year | 06 | Month | 30 | Day |
Anticipated trial start date
| 2022 | Year | 08 | Month | 15 | Day |
Last follow-up date
| 2034 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Baseline survey: self reported questionnaire
Follow-up survey: bieneal survey (self reported or online survey)
We will send participants an annual newsletter including articles about the new information on women's health from epidemiologic / medical papers of scientific journals.
Management information
Registered date
| 2022 | Year | 08 | Month | 02 | Day |
Last modified on
| 2023 | Year | 07 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055319
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
